JP2023015352A - Device and method for wound treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a device for treating wounds with negative pressure and/or therapeutic agent.

SOLUTION: A wound treatment device 20 has a chamber 22 defining a treatment space 24 having an inner surface mechanically designed. The inner surface includes a plurality of structures. The plurality of structures are configured to provide pathways for the distribution of negative pressure and to exert mechanical stress on a wound. One or more tubes may be in fluid communication with the treatment space to facilitate application of negative pressure, introduction of the therapeutic agent, and removal of wound material.

SELECTED DRAWING: Figure 1

COPYRIGHT: (C)2023,JPO&INPIT

Description

FIELD OF THE DISCLOSURE The present disclosure relates generally to wound treatment, and more specifically to devices and methods for treating wounds with negative pressure and/or therapeutic agents.

Various techniques are used to treat open wounds. In some cases, open wounds may be treated with wet or dry gauze. However, such treatment can result in excessive pain, wound dehydration, fluid and protein loss, heat loss, or delayed healing. Burn wounds may additionally be treated, such as with antimicrobial creams, to delay the appearance of infection.

Wound chambers have been developed to protect open wounds and to provide environmental control of the treatment site. For example, exemplary wound chambers and methods for their use are described in U.S. Pat. No. 11/130,490 entitled "With Remote Access Portal," each of which is incorporated herein by reference as if set forth in its entirety. there is

A wound chamber typically includes a chamber for enclosing a predetermined surface area around a wound on a patient. A wound chamber is sealed to the skin directly adjacent to the wound. However, certain wounds on and around limbs may not be treatable by wound chambers intended for use over relatively flat skin surfaces. Alternatively, it may be necessary to enclose all or part of the limb in a chamber to create a chamber environment around the wound. In addition to other features, the wound chamber can have portals for introducing treatment fluids and treatment additives into the wound chamber, and for extracting wound fluids and/or air from the wound chamber. is.

Many wounds can be treated by the application of negative pressure. Such methods of treatment have been practiced for many years. Benefits of such treatment may include reduction of edema; reduction of wound exudate; reduction of wound size; and stimulation of granulation tissue formation. Existing devices and appliances for providing negative pressure wound closure therapy are complex. Such devices typically consist of a porous insert, such as foam or gauze, placed into the wound; a tube connecting the inner space to a source of suction; a flexible cover that seals to the skin around the wound; a motorized suction pump; controls for operating the pump and monitoring the system; a container for collecting wound fluid; filters for handling material to be removed; safety systems to prevent patient harm and to block the escape of biological material into the outside environment. These devices are expensive, labor intensive, and limit patient mobility. These devices are generally not considered suitable for wounds on certain areas of the body, including wounds on the face, neck, and head. Many components are prone to leaks, especially seals around inserts and tubes. Therefore, suction must be applied either continuously or frequently.

Continuous aspiration is typically accomplished by a vacuum pump powered by an electric motor. Such systems require complex means to measure, monitor and control pump operation to ensure patient safety. Additionally, many negative pressure devices are contraindicated in the presence of necrotic tissue, invasive infections, active bleeding, and exposed blood vessels. They require the use of porous inserts (sponge, foam, gauze, mesh, etc.) in the wound. Inserts can present two problems: tissue growth into the insert and having infectious and/or unwanted material in the insert. Wound tissue can grow into and around such inserts, thereby adversely affecting the healing process. Moreover, such inserts can retain wound fluids and microorganisms and thus become contaminated and/or infected, which can adversely affect the healing process. Additionally, the high cost of these devices can prevent or delay their use for patients.

Existing negative pressure therapy devices are labor intensive. This is because it requires the user to assemble, fit and customize the number of components. First, the user must prepare, trim and size the foam, gauze, mesh or other material insert to be placed in the wound. The user must then position the tube within the insert and then cover the tube and insert with a material intended to create a leak tight seal. In practice, and as noted above, such compositions tend to leak, requiring frequent application of suction to establish and re-establish negative pressure in the space around the wound. . Additionally, currently available negative pressure devices and systems block the view of the wound, making monitoring and diagnosis more difficult. This is a particular problem with wounds on the head, neck, and face, making existing negative pressure devices unsuitable for treating such wounds.

According to one or more embodiments, devices and methods are disclosed for treating wounds with negative pressure and/or therapeutic agents.

According to one or more aspects, a kit for wound treatment can include a wound treatment device, the wound treatment device is a chamber including an inner surface and a sealing portion, the sealing portion comprising: A chamber defining an isolated treatment space and a plurality of embossed structures arranged in a predetermined pattern on an inner surface of the chamber, the structures directly contacting the wound. and a plurality of embossed structures configured to create pathways for distributing negative pressure between the inner surface of the chamber and the wound. A kit for treating wounds includes at least one tube having a first end connected to a chamber, the at least one tube being in fluid communication with an isolated treatment space and an isolated treatment space. at least one tube adapted to enable at least one selected from the group of applying a negative pressure to the treatment space and applying a therapeutic agent to the wound; and up to or at least about A therapeutic agent, including an antibiotic, formulated with the gel at a concentration of 1000×MIC.

In some embodiments, the therapeutic agent further comprises an analgesic.

In some embodiments, the formulation of the therapeutic agent comprises saline.

In some embodiments, the structures have a height of about 0.2 mm to about 5 mm and are spaced apart from each other by about 0.2 mm to about 10 mm.

In some embodiments, the structure penetrates into the isolated treatment space in a direction generally perpendicular to the inner surface of the chamber.

In some embodiments, each embossed structure is conical, pyramidal, pentagonal, hexagonal, hemispherical, domed, rod, elongated ridge with rounded sides, and square. It has a shape selected from the group consisting of elongated ridges with sides.

In some embodiments, the chamber is made from substantially impermeable materials.

In some embodiments, the chamber is made from a substantially transparent material.

In some embodiments, the at least one tube is further configured to remove wound fluids from the treatment space. In some embodiments, the kit further includes a wound fluid collection device containing absorbent material fluidly connected to the treatment space via at least one tube. In some embodiments, the collection device includes at least one of an in-line pump, a check valve, and a safety transducer.

In some embodiments, the kit further comprises a source of negative pressure in communication with the chamber via at least one tube.

In some embodiments, the kit further comprises instructions for use of the device and a therapeutic agent for wound care.

In some embodiments the gel is a hydrogel.

According to one or more aspects, a wound treatment system can include a wound treatment device, the wound treatment device being a chamber including an inner surface and a sealing portion, wherein the sealing portion is isolated A chamber defining a treatment space and a plurality of embossed structures arranged in a predetermined pattern on an inner surface of the chamber, the structures configured to directly contact the wound. a plurality of embossed structures connected to the chamber and configured to create a pathway for distributing negative pressure between the inner surface of the chamber and the wound; At least one tube having a first end, the at least one tube being in fluid communication with the isolated treatment space for applying a negative pressure to the isolated treatment space and and at least one tube adapted to enable at least one selected from the group of applying a therapeutic agent, and the wound treatment system is a wound fluid collection device comprising: The collection device can include a wound fluid collection device containing absorbent material and connected to the isolated treatment space via at least one tube.

In some embodiments, the collection device includes at least one of an in-line pump, a check valve, and a safety transducer.

In some embodiments, the wound treatment system further includes a source of negative pressure in communication with the chamber via at least one tube.

According to one or more aspects, a method of treating a wound comprises applying a wound treatment device to the wound to form an isolated treatment space; and delivering at least one therapeutic agent, including a formulated antibiotic, to the isolated treatment space.

In some embodiments, the therapeutic agent further comprises an analgesic.

In some embodiments, the method further comprises subjecting the wound to negative pressure wound closure therapy via the device.

In some embodiments, the method further comprises subjecting the wound to debridement.

In some embodiments the gel is a hydrogel.

The foregoing and other objects and advantages of the present disclosure will become apparent in the detailed description that follows. In this description reference is made to the accompanying drawings which illustrate preferred non-limiting embodiments of the invention.

In the drawings, like reference numerals generally represent the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention and are intended as a definition of the limits of the invention. Absent. For purposes of clarity, not all components may be labeled in all drawings. In the following description, various embodiments of the invention are described with reference to the following drawings.

1 is a perspective view of a wound chamber treatment device with tubing leading from the chamber to a suction source; FIG. 2 is a side cross-sectional view of the device of FIG. 1; FIG. Figure 2 is a cross-sectional view of the device of Figure 1 with additional tubing leading to the port; 2 is a cross-sectional view of the device of FIG. 1 with branch tubes leading to ports; FIG. Fig. 3 is a perspective view of the end of the tube communicating with the interior chamber space; FIG. 4 is a side cross-sectional view of structures engineered onto and into the interior surface of the chamber wall, the structures being of uniform size and shape and evenly spaced; Fig. 3 shows that they are placed apart; FIG. 11 is a schematic representation of patterned engineered structures, according to one or more embodiments; FIG. 11 is a schematic representation of a patterned engineered structure, according to one or more embodiments; FIG. 11 is a schematic representation of a patterned engineered structure, according to one or more embodiments; FIG. 4 is a side cross-sectional view of two groups of structures engineered onto and into the interior surface of the chamber wall, one group penetrating into the chamber space and the other group; are intrusive to a lesser extent, and structures from these groups alternate in a regular pattern. 3A-3C are side cross-sectional views of three groups of structures engineered onto and into the interior surface of the chamber wall, such groups having varying degrees of intrusion into the chamber space; Fig. 2 shows that they have and are alternating in a regular pattern; FIG. 10 is a view of a structure engineered onto and into the interior surface of the chamber wall, showing that the structure is composed of raised ridges. Figure 9b is a side cross-sectional view of the raised ridge of Figure 9a with rounded edges; Figure 9b is a side cross-sectional view of the raised ridge of Figure 9a with a square cross-section; 9b is a view of the raised ridge structure shown in FIG. 9a with the addition of raised dome-shaped structures positioned between the ridges; FIG. 4A is a view of a raised ridge structure engineered onto and into the interior surface of the chamber wall, showing two parallel lines of such structure forming a channel; is. A view of a raised dome-shaped structure engineered onto and into the interior surface of the chamber wall, showing two parallel lines of such structure forming a channel. It is a diagram. FIG. 10 is a diagram of a wound chamber showing a pattern of channels leading to the center of the chamber and then to a tube communicating from the interior of the chamber space. FIG. 4 is a diagram of the radiation pattern of a channel leading to a communicating tube; FIG. 10 is a diagram of a branched pattern of channels leading to a communicating tube; FIG. 10 is a sub-branching pattern of channels leading to communicating tubes. FIG. 10 is a side cross-sectional view of a fold in the chamber wall; FIG. 12B is a side cross-sectional view of a fold in the chamber wall, wherein structures are engineered onto and into the inner surface of the fold, and the structure is continuous within the fold; FIG. 10 illustrates maintaining open space; 18 is a side cross-sectional view of a fold in the chamber wall of FIG. 17 with structures engineered onto the inner surface of the fold. FIG. FIG. 10 is a drawing of a wound chamber configured as a tube for placement over a limb, showing that the wound chamber has engineered structures and channels on the inner surface of the chamber wall. is. 2 is a cross-sectional view of the device of FIG. 1 showing a fluid collector placed in front of the suction source; FIG. Fig. 2 is a cross-sectional view of a suction device in the form of a squeeze valve of deformable material; Fig. 2 is a cross-sectional view of a suction device in the form of a flexible chamber containing one or more compression springs; FIG. 2 is a cross-sectional view of a suction device in the form of a wedge-shaped chamber containing one or more torsion springs; Figure 24 is a cross-sectional view of the device of Figure 23 containing flat springs; FIG. 4 is a cross-sectional view of an aspiration device with a trap and filter built into the exhaust port; 1 is a perspective view of a wound chamber treatment device for wounds on the face, head, and neck, according to one or more embodiments; FIG. FIG. 12 is a perspective view of another embodiment of a wound chamber treatment device for wounds on the face, head, and neck, according to one or more embodiments; 1 is a perspective view of an unassembled wound chamber treatment device for wounds on the face, head, and neck, according to one or more embodiments; FIG. FIG. 12 is a front view of an assembled wound chamber treatment device for wounds on the face, head, and neck, according to one or more embodiments; 1 is a perspective view of a wound fluid collection device according to one or more embodiments; FIG. 1 is a schematic side view of a wound fluid collection device according to one or more embodiments; FIG. 1 is a schematic exploded side view of a wound fluid collection device in accordance with one or more embodiments; FIG. 1 is a perspective view of a wound chamber treatment device according to one or more embodiments; FIG. FIG. 10 is a side view of a wound chamber treatment device according to one or more embodiments; FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example. FIG. 3 represents the data discussed in the attached example.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are described in detail below. However, the description of particular embodiments is not intended to limit the invention to the particular forms disclosed, on the contrary that intent is defined by the appended claims. It should be understood that it covers all modifications, equivalents and alternatives falling within the spirit and scope of the invention as stated.

The present disclosure is directed to providing a simple, safe, disposable, cost-effective device that is easy to install and operate, allows freedom of movement for the patient, and eliminates the problems described above. Overcome, or at least reduce the effects of, one or more of them. In at least some embodiments, the present disclosure does not require the use of interface layers such as porous inserts. In some embodiments, one-piece, two-piece, or multi-piece device constructions are suitable for patient care and eliminate virtually all leaks, thus eliminating constant or frequent negative pressure. Preserve and maintain negative pressure in the wound without the need for regeneration of the wound. Additionally, the structure of the device is configured to promote wound healing and is configured to create a pathway through which negative pressure is distributed and maintained within the treatment space. can be The device can directly contact the wound without the use of interfacing layers such as porous inserts. In some embodiments, the device can be used in conjunction with sustained release therapeutic agents. The therapeutic agents can be formulated, for example, with biomaterials, etc., as further described herein. A biomaterial can be naturally occurring and biocompatible. In some embodiments, a biomaterial can be cross-linked with a therapeutic agent. A biomaterial may be selected based on its properties. In some embodiments, the biomaterial can be, for example, a hydrogel, hydrocolloid, alginate, or any other gel. The device may be made from substantially impermeable materials to promote healing and facilitate use of therapeutic agents. A wound exudate collection device can interface with and be used in conjunction with a treatment device. What is presented with respect to this disclosure can be extended beyond the limitations imposed by current devices. The cost-effectiveness of the present disclosure can result in the provision of negative pressure wound closure therapy to a wider extent and earlier in the wound care timeline.

According to various aspects and embodiments, the devices and methods of the present disclosure can be used to treat full and partial thickness burns, traumatic wounds, post-surgical wounds, infected wounds, post-infected wounds. , skin loss due to dermatological lesions, and other lesions that result in skin and deep tissue loss. In some non-limiting embodiments, the patient may have a total body surface area (TBSA) injury of about 5% to about 30% or more. In some embodiments, the wound can be a bilateral wound. Wounds may be acute or chronic. In at least some embodiments, the deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone may be exposed due to the nature of the wound. The devices and methods may be used anywhere on the human body and may also be suitable for veterinary applications. The devices and methods can be used, for example, for wound conditioning to prevent scarring, and for fixation and protection of skin grafts during wound healing. In certain non-limiting embodiments discussed herein, wound treatment may involve disorders occurring on the head, face, and/or neck. For example, the patient's cheeks, forehead, and/or crown can be treated. The head, including facial tissue, presents unique challenges that may be addressed according to one or more embodiments.

One aspect of the present disclosure is found in a wound treatment device that includes a chamber that defines a treatment space around a wound. The flexible adhesive base of the chamber forms a watertight and airtight seal. A tube communicates from the treatment space to a source of suction. In at least some embodiments described herein, the suction source is capable of generating and/or maintaining a sub-atmospheric pressure within the enclosed space. The suction source also serves as a receptacle for material removed from the chamber, including wound fluids. All components are preferably inexpensive, lightweight and disposable.

1 and 2, illustrations of a wound treatment device 20 are provided. Device 20 includes a chamber 22 defining a treatment space 24 and a base 26 that can be sealed to a patient's skin surface 28 over a wound 30 . In the illustrated embodiment, chamber 22 has a bellows configuration with folds 23 . However, the invention is not so limited, and other configurations of chambers formed from flexible, moisture-impermeable, and gas-impermeable materials may also be used. Also, the chamber can be transparent, allowing visual inspection of the wound during treatment. According to a particular embodiment, the material is substantially transparent. In other embodiments, the material can be substantially opaque. The use of impermeable materials is particularly advantageous for introducing therapeutic agents to wounds. Additionally, the impermeable nature of the chamber material prevents water loss from the wound, which promotes improved healing. The materials from which device 20 can be made will be discussed in greater detail below. Device 20 may be designed for use with any wound on any body part, including both human and veterinary applications. Various geometries such as circular, square, rectangular, tubular, pouch, envelope, or other shapes can be implemented based on the intended application. According to some embodiments, the chamber 22 defining the treatment space 24 may be configured with respect to a particular body part. For example, a chamber in the form of a tube or sleeve for placement over a limb is shown in FIG. 19, while a chamber in the form of a hood for placement over the head is further described below. As shown in FIG.

According to one or more embodiments, the geometry of the wound treatment device chamber can generally be with some degree of convexity or concavity, e.g., for negative pressure wound closure therapy applications. It is adapted to allow it to be pulled down, such as when contacting, for example, a deep or full thickness wound. In some non-limiting embodiments, the material used to form the chamber and/or its shape may lend itself to this design in terms of matching the contours of the anatomy and/or wound. It is possible. In some embodiments, the device can be a concave structure, the concave structure generally hollowed inward toward the wound. The main redundancy of the construct (concave with respect to the device) is highly desirable in certain cases such as deep wounds. In deep wounds, the underside of the generally concave device can be pulled into all deep portions of the wound to provide negative pressure wound closure therapy and micromechanical forces across the deep wound surface. An additional reason for the redundant construction of the device is to provide folds that extend deep into the wound, thus creating channels for air and fluid flow.

Still referring to FIGS. 1 and 2, a dermal or skin adhesive material may be provided on the bottom surface of base 26 to provide sufficient adhesive strength for a fluid-tight seal and chamber 22. to prevent inadvertent removal of the fluid-tight seal during normal patient movement. Numerous adhesive materials sufficient for these purposes are known to those skilled in the art.

According to some embodiments, device 20 may be specifically designed to treat wounds that occur on the head, face, and/or neck. The device can cover only the head or cover both the head and neck. Referring again to FIG. 26, a chamber can be formed that fits over the head and attaches to the base of the neck, eg, at or near the collarbone. In some embodiments, the chamber may be defined by a single piece of material, or a two or more piece design may be implemented. The device can be oversized or customized to fit any size head. An oversized device can lead to the presence of wrinkles in use, which can be advantageous for negative pressure distribution. According to another embodiment, and with reference to FIG. 26, the device may consist of two pieces 201A and 201B, for example around the midline of the head and , across the ears and can be joined with an adhesive to form a seam 202 . In some embodiments, the pieces may be joined by other methods, for example, by a zipper type or Ziploc® seal. Further, according to other embodiments, and as shown in FIG. 27, the device may be formed from multiple pieces that contour the face.

The head device may or may not have openings for the nose and mouth. If the device is constructed to cover the nose and mouth, the nose and mouth may be surgically sealed for treatment. For example, a soft conforming obturator or, alternatively, a suture may be used. Referring to FIG. 28, a patient being treated with device 20 covering the nose and mouth is allowed to breathe through an installed tracheostomy tube 203 and through an installed gastrostomy tube 204. can be fed via These tubes can be fitted to the outside of the device, for example at the neck. Contact lenses (not shown), such as oversized lenses, may be used to protect the eye during treatment.

A tube 32 is preferably attached to the chamber 22 at spaced locations above the base 26 and communicates with the treatment space 24 . Tube 32 is constructed to maintain its shape without collapsing and is constructed to allow passage of wound fluids and wound debris. Tube 32 may be permanently affixed to chamber 22, or fittings, such as tubular port 25, may be used to attach and remove tube 32 or to deliver materials or therapeutic agents to treatment space 24; Alternatively, it may be provided to allow attachment and removal of any other device capable of removing material from treatment space 24 . Tube 32 can terminate at the wall of chamber 22 or tube 32 can extend a predetermined distance through the wall and terminate within treatment space 24 . , where the tube 32 can communicate with such space by a channel formed on the inner surface of the chamber wall or by a fold formed in the chamber wall. . Tube 32 is sealed to chamber 22 to prevent escape of liquids or gases from treatment space 24 to the outside environment. The distal end of tube 32 terminates in a device that generates subatmospheric pressure, such as suction device 34 . Suction device 34 can be a pump, but other types of devices can also be used, as discussed below. A fitting 33 may be provided to allow removal and reattachment of suction device 34 to tube 32 .

Referring to FIG. 28, when device 20 is used to treat wounds on the face, head, and/or neck, device 20 includes a plurality of tubes for communication with one or more tubes 32. A tubular port 25 may be included. Ports 25 may be strategically placed based on the geometry of the chamber. At least one tubular port 25 may be positioned at the top of the device and at least one tubular port 25 may be positioned at the bottom of the device. According to some embodiments, tubular port 25 may be positioned at the temple on the side of the patient's face, close to the ear. In some embodiments there are at least two tubular ports.

Turning to FIG. 3, a cross-sectional view of device 20 is provided, which shows second tube 35 attached to chamber 22 and through the channel. , or communicate with treatment space 24 by folds. The distal end of tube 35 terminates in portal 36 . The present disclosure is not limited to any number of communicating tubes, multiple tubes and portals may be provided to access treatment space 24 . FIG. 4 shows the device of FIG. 1 with a branch of tube 32 leading to portal 36 . Portal 36 may be used for delivery of therapeutic agents (eg, antimicrobials, antibiotics, antifungals, analgesics, etc.) before, during, or after delivery of negative pressure. As such, portal 36 can be a luer configured to attach to a container or syringe. Alternatively, therapeutic agents may be delivered through the same tube 32 that communicates with suction device 34 .

According to some embodiments, the device can allow delivery of therapeutic agents directly to the wound. As such, therapeutic agents can be delivered at significantly higher concentrations than they could otherwise be administered intravenously or orally. For example, antibiotics are applied directly to wounds at concentrations ranging from approximately conventional oral concentrations to about 1000 times conventional oral concentrations (i.e., 1000 x MIC), or even higher concentrations. obtain. These concentrations would be harmful to the body if ingested or administered directly into the bloodstream. Topical application facilitates the use of significantly higher concentrations that promote healing. Combinations of therapeutic agents, such as analgesics, antibiotics, and chemical or enzymatic debridement agents, may also be used, advantageously reducing the need for surgical wound debridement. or can be eliminated. The therapeutic agent can be delivered at concentrations from 1-fold the MIC to at least 1,000-fold the MIC. In some embodiments, concentrations up to 5,000 times the MIC may be used during shorter periods of treatment. In large wounds, for example, the limiting factor may be systemic toxicity from wound absorption. Due to the combination of half-life absorption and surface area, the total amount of pharmacological agent should generally be limited to 5 times the standard total IV dose over a 24 hour period. In some non-limiting embodiments, concentrations of 1,000 to 5000 X MIC can be administered safely and effectively. In other non-limiting embodiments, concentrations of 15 to 500 to 1000 X MIC can be administered safely and effectively and may find particular utility, for example, in various military applications. . Concentration, volume, absorption rate, and surface area can all be considerations and defined variables in terms of precise targeted delivery of various therapeutic agents according to various embodiments. In various embodiments, wound treatment devices as described herein can be used to form a reservoir of formulated therapeutic agents to drive their utility for healing. be. Use of the device in combination with the formulated therapeutic agents described herein can demonstrate synergy in terms of efficiency of wound healing.

According to one or more embodiments, one or more therapeutic agents may be formulated and delivered for improved efficacy and/or usability associated with wound therapy devices. The analgesics and/or antibiotics and/or antifungals and/or debridement chemicals and/or anti-inflammatory agents and/or scar reduction agents and/or chemotherapeutic agents, whether small molecules or macromolecules. The wax can be delivered to the wound site. In some embodiments, therapeutic agents may be formulated for sustained release to allow for long-term care. Also, maintenance of the desired placement of therapeutic agents to the wound may be driven by their formulation as described herein. High-dose local treatment of wounds is not possible systemically, but can be enabled through the delivery of active therapeutic agents in liquid or gel form to the device. In some embodiments, the antibiotic can be gentamicin, vancomycin, clindamycin, minocycline, or tetracycline. In some embodiments, the antifungal agent can be diflucan or amphotericin. In some embodiments, the analgesic can be lidocaine. In some embodiments, the anti-inflammatory agent can be a steroidal or non-steroidal anti-inflammatory drug such as indomethacin or aspirin. In some embodiments, the scar-reducing agent can be cortisone. In some embodiments, the chemotherapeutic agent can be 5FU. One or more of these and a variety of other therapeutic agents may be implemented alone or in combination.

In some embodiments, one or more therapeutic agents or combinations thereof may be formulated with a gel for delivery to the wound site. As discussed, hydrogels, hydrocolloids, alginates, or any other gels may be used herein. A formulation may be formed and then delivered to a wound treatment chamber. Alternatively, a gel may be positioned within the wound treatment chamber prior to delivery of one or more therapeutic agents. Sustained release delivery of one or more therapeutic agents can be provided from the gel reservoir. A layer of gel may be applied, such as a layer 2 mm to 10 mm thick. In one embodiment, a 3 mm thick layer of gel can be used and the total amount of gel can be 100 ml (100 cc). For example, when using vancomycin or gentamicin, the MIC is typically approximately 2 micrograms per ml or cc for common bacteria. A total of 200 mg of each of these antibiotics may be required in 100 ml of gel. For the purposes of example only, an upper arm with a surface area of approximately 2,000 square centimeters would use 60 cc of gel based on a 3 mm thick layer.

Hydrogels are typically three-dimensionally cross-linked networks composed of hydrophilic polymers with high water content. Hydrogels, gels, hydrocolloids, alginates, methylcellulose, gelatin, or any other gels can impart sustained release characteristics to the therapeutic agent and also render the therapeutic agent suitable for the wound being treated. It is possible to promote keeping in place. For example, the gel can allow the therapeutic agent to be released for at least 24 hours, at least 48 hours, at least 72 hours, or at least 96 hours. The half-life of the active antibiotic is approximately 24 hours, 48 hours, 96 hours, or more for embodiments requiring gels and/or sustained release formulations of antibiotics and/or analgesics. It can be a long time. Drug release kinetics can be controlled by drug diffusion through the network. Polymer concentration and molecular weight, as well as the type and degree of chemical and physical cross-linking, allow manipulation of the gel's physical properties, such as viscoelasticity and drug release kinetics. For example, alginates may be used in various formulations of therapeutic agents to achieve an acceptable viscosity range. A relatively high viscosity may be a desirable property to facilitate healing, as is a relatively low freezing point.

A gel may be selected for at least one of its properties. For example, the gel can be selected for its pre-gel rheological properties, post-mechanical gelling stability, or control over the release of incorporated therapeutic agents. Prior to gelation, the gel precursor can have a sufficiently low viscosity to allow it to flow into the mold and conform to the skin-facing side of the device. . Following gelation, the gel must possess adequate stiffness to maintain its shape and not allow leakage from the device if it is ruptured, and It must be sufficiently robust to prevent its crushing as the device is handled.

According to Table 1, gel therapeutic formulations containing antibiotics and 0.5% (agarose) hydrogel can be stable for up to 1 week. The drug passively dissolves into the gel and remains stable over time. In some embodiments, the gel therapeutic formulation can further comprise saline. A gel can be biocompatible, meaning that it is structurally similar to the extracellular matrix in tissue. The gel may be flowable, allowing, for example, either casting into a mold or injection via a needle through a port. Loading of the hydrogen therapeutic agent formulation within the device allows for consistent and uniform contact with the skin and maintains continuous delivery of the therapeutic agent to the underlying tissue, even with patient movement. is possible. Gel therapeutic formulations can prevent loss of therapeutic agent in the event of small leaks in the adhesive of the device.

In some specific non-limiting embodiments, the gel can include naturally occurring polysaccharides. In some embodiments, the gel can comprise alginate, agarose, hydrocolloid, or cellulose, or combinations thereof. In at least some embodiments, the gel can be a hydrogel.

In at least some embodiments, both antibiotics and analgesics may be implemented to reduce or eradicate infection and to relieve pain.

In some embodiments, the gel may be lyophilized before or after loading into the device to minimize weight and facilitate storage, stability, and transportation.

According to one or more embodiments, the engineered skin-facing surface of the device chamber (an embossed pattern as further described below) is applied to the gel formulated treatment. It is possible to promote uniform distribution of the agent. Also, devices such as those described herein are capable of facilitating slow or sustained release of therapeutic agents.

According to one or more embodiments, a wound treatment device can provide a sterile enclosure, which is applied immediately after injury and for precise local delivery of protective dressings and therapeutic agents. It is possible to provide tools for The device can also serve as a wound incubator for strategic tissue regeneration in a controlled environment. Thus, the device can address the problems of wound depth progression, infection and sepsis from the first treatment and throughout the treatment process in both military personnel and civilians. Beneficially, long-term field care and/or evacuation can be safely and comfortably endured until reaching advanced medical facilities. Rapid decontamination, reduced pain, reduced inflammation, reduced tissue loss, less scarring, and improved quality of healing can all be promoted.

In some embodiments, the device may be applied to a fresh wound within 24 hours of injury. According to one or more embodiments, the device can remain in place for up to about 4 to 7 days or more before being completely replaced or removed. Wound fluids can be removed and therapeutic gel can be added to the device through the port. A transparent device can allow for wound assessment. A sleeve may be placed over the device for additional protection. The device can be suitable for single use, sterile packaging for single use, disposable. The gel can be rehydrated after storage.

According to one or more embodiments, combination and/or sequential treatment regimens may be practiced. The device may be applied after hemostasis. The wound can be debridemented for a period of time and then treated with the devices and formulated therapeutic agents described herein. In some non-limiting embodiments, the disclosed therapeutic agents are left in place on the wound for up to a week or more before the wound is further evaluated to determine further treatment steps. can be Beneficially, the wound can be left in the sterile environment of the disclosed device for an extended period of time to promote healing. Moreover, the formulated therapeutic agent also promotes a relatively uninterrupted period of wound therapy. In some embodiments, a period of negative pressure wound closure therapy can be applied to the wound via the disclosed devices as described herein. Such therapy can be continuous or periodic, and can occur concurrently with, prior to, or subsequent to application of the formulated therapeutic agent. In at least some embodiments, negative pressure therapy can be used sequentially with drug delivery. In certain embodiments, negative pressure therapy is not administered concurrently with drug delivery, for example, as it can be a separate approach from conventional wound irrigation techniques.

Turning now to FIG. 5, the end of tube 32 extending into chamber space 24 is shown with a plurality of holes 44 . The purpose of the holes 44 is to ensure that gases, liquids, wound fluids, debris, and other materials can flow and move from the chamber space 24 into the tube 32 without obstruction. .

A wound may advantageously be monitored through the substantially transparent chamber material. Negative pressure device 20 may also be equipped with sensors to monitor certain parameters within chamber space 24 . For example, oxygen, carbon dioxide, pH, temperature, and other parameters can be measured and monitored.

Referring to FIG. 6, the interior surface of the chamber wall may be configured with structures 40 that are engineered onto the surface. Figures 6a-6c present schematics of different patterned engineering structures according to one or more non-limiting embodiments. The portion of the interior surface with engineered structures 40 may vary from that shown in the figures, preferably a high percentage of the interior surface comprises engineered structures 40 . The structure preferably covers at least 50% of the internal surface, more preferably at least about 95% of the internal surface. These structures are raised when viewed from within chamber space 24, and they extend into such space in a direction generally perpendicular to the interior surface of chamber space 24. invading. These structures can be of any shape, including but not limited to cones, pyramids, pentagons, hexagons, hemispheres, domes, rods, rounded sides. elongated ridges or elongated ridges with square sides. The structures may be provided as identical shapes or in any combination of shapes. The structures can be provided in the same size or in any combination of different sizes. The structures may be provided in regular or irregular patterns on the surface. The distance of penetration by such structures from the chamber walls into the chamber treatment space 24 (height of such structures) is preferably between 0.01 mm and 20 mm, preferably 1 mm. to 1 cm, most preferably about 2 mm. The spacing between such structures is preferably between 0.01 mm and 5 cm, the spacing being, for example, most preferably about 2 mm apart. In some embodiments, structures about 2 mm tall are spaced about 2 mm apart. When larger structures are used, the structures may be spaced further apart, and when smaller structures are used, the structures may be spaced closer together. For example, pyramid configurations with a height of 0.2 mm may be spaced apart by about 0.2 mm, while larger pyramid configurations with a height of about 5 mm are spaced apart by 10 mm. obtain.

Engineered structure 40 interfaces with the wound surface during use of device 20 . The engineered structure can directly contact the wound surface. One purpose of these structures is to ensure that the negative pressure established within chamber space 24 is uniformly distributed and maintained throughout such space. When negative pressure is established in the tube and it is connected to a source of suction or sub-atmospheric pressure, the chamber will lie tighter against the wound tissue. Device 20 is used to define a pathway for establishing, distributing and maintaining negative pressure across the wound surface and to prevent complete contact between the inner surface of the chamber and the wound tissue. includes an engineering structure 40 . Without such a structure, the chamber walls would be in full contact with the wound surface. As a result, there is no space within which negative pressure can be established, distributed, and maintained. Therefore, the engineered structure is preferably semi-rigid. The term "semi-rigid" should be understood to mean that deformation occurs only at the microscopic level under operating negative pressures in the range of 0.5-2 psi. Alternatively, the engineered structures can be somewhat flexible depending on the spacing between the structures. In addition, the structures are engineered to reduce the extent to which wound tissue can enter the spaces between the structures, such that a sufficient amount of open space is maintained. It has become. Engineered structures can be strategically patterned onto the surface to create the desired negative pressure pathways within the chamber.

An additional purpose of these structures is to serve as a form of stimulation to the wound and produce beneficial results including, but not limited to, granulation tissue formation and increased micromechanical force. That is. Such mechanical force provides stimulation to a portion of the wound tissue, which has been proposed as a contributing factor to the effectiveness of negative pressure wound closure therapy. From the discussion and figures above, it should be understood that the flexible chamber is movable over a range of predetermined positions. The range of positions includes a first position, such as the positions shown in FIGS. are spaced apart from The range of positions also includes a second position, where at least some of the engineered structures 40 are positioned within the opening of the chamber. The second position is preferably where the engineering structure 40 engages the wound.

The chamber walls have the following attributes: flexibility, conformability, gas impermeability, liquid impermeability, ability to be formed, crafted and engineered, and shade. It may be formed from any suitable medical grade material that has the ability to retain the shape, function and effectiveness of the raised structure under the desired range of pressure. Materials should generally discourage attachment and ingrowth. The material is preferably transparent to allow visual inspection of the wound during treatment. In addition, the materials are preferably hypoallergenic and provided to medical facilities under sterile conditions. For example, the chamber device may be made from flexible, conformable materials such as polyurethane, polyethylene, or silicone, although other similar materials may also be used. The material can have a thickness ranging from about 5 mm to about 100 mm. In some embodiments, the material can have a thickness from about 1 mil to about 100 mils. In some specific embodiments, a 5 mil polyurethane membrane can be used to form the treatment chamber.

The chamber is preferably designed to provide sufficient material to lie against the surface of the wound tissue without special sizing, trimming, or other customizing operations. The chamber can be made from a single ply of material, or can be constructed from multiple layers of material into which and onto which the structure is engineered. A single ply chamber may be made from multiple sheets of material during manufacturing, but is provided to the medical facility with the multiple sheets bonded or otherwise connected together. It should be understood that For example, individual three-dimensional shapes can be attached or bonded to the inner surface of the chamber walls during manufacturing to provide engineered structures. Also, a single ply chamber can be formed from a single sheet of material that defines both the chamber walls and the engineering structure. For example, engineering structures can be embossed. Alternatively, multiple layers of chambers are provided to medical facilities with layers of material stacked to form the chamber. For example, the layer facing the internal treatment space of the chamber is a layer containing engineered structures that is bonded onto a generally planar layer (or multiple sheets of generally planar layers) of material by the physician. is possible.

Engineered structures may be made by techniques well known to those skilled in the art, such as embossing, stamping, molding, forming, bonding, or the like. If the structures are produced by embossing their shapes into the material, the embossed structures are concave with respect to the outside of the chamber, as shown in FIG. can be left with Alternatively, the embossed structure can be formed on a single ply of material that also forms the walls and base of the chamber. This can provide a chamber that is relatively flexible with a semi-rigid structure over a single ply of material. Alternatively, the cavity can be filled with a suitable material to solidify the structure. As another alternative, a solid structure can be affixed to the inner surface of the chamber.

The raised structures on the inner surface of the chamber wall can be configured and distributed in multiple patterns. For example, FIG. 6 is a side cross-sectional view of a portion of a chamber wall showing engineered structures 40 on the inner surface of the material facing treatment space 24 . The structures 40 are identical in shape and size and are positioned uniformly apart from each other. As another example, FIG. 7 is a cross-sectional side view showing engineering structures 41 and 42 penetrating into the chamber space, with structure 41 penetrating farther than structure 42. and the structure is organized in a regular alternating pattern such as 41-42-41-42 and so on. As yet another example, FIG. 8 is a side cross-sectional view showing engineering structures 43, 44, and 45 penetrating into the chamber space, where structure 43 structure 44 is less intrusive than structure 43, but more intrusive than structure 45, which is more intrusive than structures 43 and 44. less intrusive. These structures are arranged in regular alternating patterns such as 43-45-44-45-43-45-44-45-43. The embodiment shown in Figure 8 makes it difficult for soft wound tissue to penetrate all of the space between the raised structures. A sufficient amount of continuous space is established to allow distribution of negative pressure and addition of fluids and therapy, as well as removal of fluids and materials from the wound. As yet another example, Figure 9a is a view of a portion of a chamber wall showing engineered structures 47 in the form of raised ridges. Engineering structures 47 can be rounded (FIG. 9b), squared (FIG. 9c), or a combination thereof when viewed from the side. As yet another example, FIG. 10 is a schematic showing an engineered dome-shaped structure 48 interspersed with ridge structures 47 . The engineered domed structure 48 is preferably hemispherical when viewed from the side, although other shapes are contemplated.

Negative pressure distribution and maintenance within the chamber device and at all points over the wound are defined channels as pathways between raised engineered structures for distribution of negative pressure. • Can be enhanced by providing space. However, a defined channel space is not required to provide a fluid pathway within the treatment space. FIG. 11 is a view of a portion of the chamber wall showing that structures 47 are arranged in two parallel lines to form channel 49 . FIG. 12 shows a channel 49 formed by two parallel lines of raised dome-shaped structure 48 . Such channels can be configured in various patterns, such as radial, circular, concentric, or branched. FIGS. 13-16 show an overview of the pattern of channels 49 leading from tube 32 along the interior surface of chamber 22 facing treatment space 24 . For each pattern, channels 49 define spaces that open directly into treatment space 24 . The space preferably opens into treatment space 24 over the length of channel 49 .

Also, the distribution and maintenance of negative pressure at all points within the chamber device and over the wound may be achieved by squeezing the chamber walls to create additional channel space for the distribution of negative pressure. can be reinforced by using folds in the When negative pressure is established in the chamber, the material will tend to fold along the preformed location. FIG. 17 shows channels 50 formed in the folds of the chamber wall. Channel 50 defines a space that opens directly into treatment space 24 . The space preferably opens into treatment space 24 over the length of channel 50 . In order to increase the amount of channel space within such folds, the walls of the folds may be configured with structures that prevent the collapse of such spaces, which structures provide negative pressure. Ensure continuous open space for distribution and maintenance, and pathways for liquids, gases, and other materials. As an alternative, FIG. 18 a shows an engineered structure 52 that prevents complete collapse of the folds and ensures a continuous channel space 51 . All channel spaces created on the inner surface of the chamber wall or created by folds serve as a means for increasing the effectiveness of distributing and maintaining negative pressure within the chamber. It also serves as a means for enhancing the effectiveness of removing gases, liquids, wound fluids, debris, and other materials from the chamber treatment space. As another alternative, Figure 18b shows an embodiment similar to that shown in Figure 17 with the addition of engineered raised structures 52 on either side of the fold. Engineered structures 52 are provided to prevent the folds from collapsing to the point that all of their internal surfaces form a tight seal against negative pressure transfer. However, some of the internal surfaces, such as those adjacent to the folds, preferably contact the wound and provide stimulation as discussed above. The folds described in the previous embodiments are preferably formed into specific defined areas by molding or embossing the surface of chamber 22 .

Figure 19 shows a wound chamber device 120 for delivering negative pressure and therapeutic substances in the form of a tube that can be placed over a limb. The wound chamber device 120 is generally cylindrical in shape and includes an open end and a closed end, although the chamber can have other shapes to accommodate other body parts, It can also be suitable, for example, to fit over the head. The open end is preferably sealed by a cuff or neck (not shown), and the open end may include an adhesive on the interior surface. Wound chamber device 120 includes engineered structures 40 and channels 49 on the inner surface of the chamber wall.

As shown in FIG. 20, a fluid collector 60 may be positioned over tube 32 between chamber 22 and suction device 34 . Collector 60 is intended to receive fluid extracted from chamber space 24 and debris or material from a wound, and is intended to store such material for final disposal. there is Collector 60 may be removable from tube 32 to replace a full collector with an empty collector.

Suction for the wound treatment device is provided by a suction device 34, which can be a pump, which is connected to the chamber device by suitable connectors to provide sub-atmospheric pressure. connected to and disconnected from. The wound chamber can be used with a motor-driven pump, but it is also effective with a manual device operated by the caregiver or patient. The manual device can be a squeeze valve, which provides suction through energy stored in the material of its construction. Alternatively, the suction device may be powered by a spring that is compressed by the user. The spring can be selected to create a clinically desired level of negative pressure. The amount of suction provided by these suction devices therefore depends on the material being compressed or the level of force generated by the spring. Unlike motor-driven suction pumps, manual devices preferably cannot create high levels of suction that can adversely affect wound healing.

Referring to Figure 21, a suction device 61 in the form of a valve constructed from a deformable material that stores the energy of deformation can be used. Tube 32 communicates with the interior of suction device 61 . The one-way exhaust valve 62 also communicates with the interior of the suction device 61 . When the user squeezes the suction device 61 , the air inside the device is expelled through the exhaust valve 62 . A portion of the energy used to deform the suction device 61 is stored in the material of which the suction device 61 is constructed and thus within the device and of the tube 32 and chamber space 24 . During, maintain suction. The valve is selected and engineered to maintain a constant force and to maintain a clinically desired level of negative pressure within the chamber space 24 . Fluid from wound 30 is allowed to flow through tube 32 and into suction device 61, where it is stored prior to disposal. When the suction device fills with fluid, negative pressure generation stops. Thus, the fluid volume of the suction device acts as a safety shut-off mechanism without the need for electronic sensors and controls.

FIG. 22 shows an alternative suction device 63 , consisting of flexible sides 64 and rigid sides 65 . A compression spring 66 is positioned within the suction device 63 . Both tube 32 and exhaust valve 62 communicate with the interior of suction device 63 . When the user squeezes rigid sides 65 toward each other, spring 66 is compressed and air within the device is expelled through one-way exhaust valve 62, thus exiting the device as well as tubing 32 and A suction is maintained in the chamber space 24 . Springs 66 are selected and engineered to maintain a constant force against rigid sides 65 and to maintain a clinically desired level of negative pressure within chamber space 24 . is designed to Fluid from the wound 30 is allowed to flow through the tube 32 and into the suction device 63 where it may be stored prior to disposal of the entire device 63 . Also, the suction device will stop working when it is filled with fluid.

FIG. 23 shows an alternative suction device 70 consisting of a rigid side 72 joined by a hinge 73 and a flexible side 71 . . A torsion spring 74 is attached to either the interior or exterior of the rigid side 72 . Both tube 32 and exhaust valve 62 communicate with the interior of suction device 70 . When the user squeezes the rigid sides 72 toward each other, the springs 74 are compressed and air within the device is expelled through the one-way exhaust valve 62, thus exiting the device as well as the tube 32 and A negative pressure is maintained within the chamber space 24 . Springs 74 are selected and constructed to maintain a force against rigid sides 72 and to maintain a clinically desired level of negative pressure within chamber space 24 . . Fluid from the wound 30 is allowed to flow through the tube 32 and into the suction device 70, where it may be stored prior to disposal of the entire device. FIG. 24 shows the device of FIG. 27 with the torsion spring 74 replaced by a flat spring 78. FIG.

As with previous suction devices, once suction is established, fluid is allowed to flow from the wound to the suction device where it can be collected and stored for final disposal. Alternatively, a separate fluid collector, such as fluid collector 60 in FIG. 20, can be positioned between the chamber and the suction device. Suction stops when the suction device expands to its original shape. The suction device will not continue to operate and can be disconnected and discarded. A new suction device can be connected and activated when treatment is to be continued.

FIG. 25 is a cross-sectional view of a trap 80 and filter 82 interposed between the suction device 34 and the exhaust valve 62 for the purpose of preventing liquid or aerosol discharge from the suction device.

The present disclosure can be engineered to operate at varying levels of negative pressure according to clinical diagnostics. Conventional negative pressure wound healing devices are capable of applying negative pressure between -0.5 psi and -2 psi, or between about -750 mmHg and about -125 mmHg. The disclosed device operates efficiently in this range. The chamber material conforms to the shape of the wound and the embossed protrusions maintain their shape and functionality. However, chambers can be engineered to operate at higher levels of negative pressure. Devices of the present disclosure are also capable of working effectively at less negative pressures, for example from about -125 mmHg to about -10 mmHg. Application of less negative pressure can reduce pain and other complications. Additionally, if a manual suction device is used, the operating pressure of the device can be higher than the generally accepted range, i.e., the device will Additionally, it is possible to operate at pressures near 0 psi.

According to one or more embodiments, a negative pressure wound closure therapy device is used to stimulate blood flow and new blood vessel growth, to biomechanically stimulate cells to encourage division and proliferation, and It can be vacuum-assisted to remove factors that can inhibit healing, such as, bacteria, and the like. Depending on the stage of treatment, the connecting tube can be plugged into different devices to apply negative pressure, to drain the wound, and to deliver the therapeutic agent.

The present disclosure eliminates many of the drawbacks to existing negative pressure wound closure therapy systems. For example, the disclosed device is preferably simplified, lightweight, and allows visual inspection of the wound. In some embodiments of the present disclosure, patients are not limited to power sources or battery packs. The system can be easily donned such that the patient's mobility is not otherwise compromised. Additionally, the wound interface appliance can be applied quickly without the need for custom fittings and construction. The device is preferably leak proof due to the smooth adhesive base and eliminates the need for constant suction from an electric pump with advanced controls and safety measures. There are no interfacing materials such as porous wound inserts that could potentially cause tissue ingrowth and carry infectious material. Instead, the inner surface of the chamber is generally non-porous and non-adhesive to prevent any interaction with wound tissue. In addition, the suction pump preferably has built-in safety limits for suction force, duration of operation, and overfilling of the collector for wound fluid. Engineered surfaces can stimulate wounds and create efficient pathways for the distribution of negative pressure. The wound treatment chamber can be customized for use on any body part, including limbs, and head, face, and/or neck. The devices and methods disclosed herein may be used in conjunction with conventional wound debridement and grafting techniques without any contraindications. Devices and methods can facilitate anchoring and protection of dermal grafts and micrografts. Devices and methods can be superior to conventional approaches to administering negative pressure, at least from a granulation tissue formation standpoint.

According to one or more embodiments, a wound treatment device may be used in conjunction with a wound fluid collection device. Accordingly, a wound treatment system can include a wound treatment device and a wound fluid collection device. The collection device can include absorbable materials such as absorbable inserts. Any resorbable material readily known to those of ordinary skill in the art (preferably biocompatible from a disposable perspective) may be implemented. The absorbable material can at least partially fill the compartment defined by the wound fluid collection device. The collection device insert is capable of absorbing wound fluid and packaging it for disposal during operation. All components are preferably inexpensive, lightweight and disposable. In at least some embodiments, the wound fluid collection device is capable of operating substantially as a filter or water trap.

Referring to Figure 30, a diagram of a wound fluid collection device 300 is provided. The device is intended to receive fluid, debris, exudate, or other material removed from the wound during treatment or therapy, and may store such material for final disposal. intended. The device includes a compartment 310 that defines a collection space. In the illustrated embodiment, the compartment has a pillow-shaped configuration. However, the invention is not so limited and other configurations of compartments formed from flexible, moisture-impermeable and gas-impermeable materials may also be used. The use of impermeable materials is particularly advantageous in preventing fluid loss from the compartment. The materials from which devices can be made vary. In some non-limiting embodiments, the collection device chamber can be made from the same material as the treatment device chamber.

The device can be designed for use on any body part, including both human and veterinary applications, with any wound care device as described herein. Various geometries such as spherical, cubic, parallelepiped, tubular, pouch, envelope, or other shapes can be implemented based on the intended application.

In some embodiments, a wound fluid collection device can include an absorbent insert 320 . The absorbent insert 320 may be made from a substrate such as an absorbent or superabsorbent material. The absorbent material can be in sheet, powder, granule or other form in the dry state. The absorbent material can be, for example, any hydrophilic polymer or any porous, fibrous, synthetic or non-synthetic material. Absorbent materials can include gels or polymers. For example, the absorbent material can be a synthetic polymer or a naturally occurring polymer. Absorbent materials are generally capable of swelling when liquid is absorbed. The absorbent material can be gelled by the wound material. In some embodiments, the walls of the wound fluid collection chamber 310 are allowed to swell as fluid is absorbed. The absorbent insert 320 can prevent collapse of the container when negative pressure is applied. In some embodiments, the container may be constructed from the same impermeable material that constructs the superstructure of the wound treatment device. The material may be embossed with the embossed portion facing inward into the container, thus allowing or promoting air flow through the fluid trap. It is designed to provide a pathway for flow. In at least some non-limiting embodiments, the absorbent insert is capable of loading at least 500g of wound material.

The collection device 300 can include a first tube 330 in fluid communication with the chamber of the wound treatment device. Collection device 300 can further include a second tube 340 in fluid communication with a source of suction. In at least some embodiments described herein, the suction source is capable of generating and/or maintaining sub-atmospheric pressure within the enclosed space. The device can include an in-line pump. A one-way valve between the wound treatment device and the fluid collection device can prevent back leakage into the wound treatment device. A safety device, such as a transducer, can be included on the pump side so that air flow can be automatically cut off when the absorbent material becomes sufficiently saturated.

FIG. 31 is a schematic side view of a wound fluid collection device according to one or more embodiments; It is illustrated that a piece of material can be folded and sealed on the remaining three sides around the perimeter to form a collection device. FIG. 32 is a schematic exploded side view of a wound fluid collection device according to one or more embodiments; Figure 32 illustrates that the compartment 7 can contain both cotton material as well as laminated absorbent sheets. A check valve (one-way) 10 prevents backflow into the wound treatment device and the transducer 3 serves as a safety measure as explained above.

In some embodiments, the wound fluid collection device is disposable and complies with regulations for disposal of industrial waste materials. In some embodiments of the present disclosure, patients are not limited to power sources or battery packs. The collection device can be easily used so that the patient's mobility is not otherwise compromised. In addition, the suction pump preferably has built-in safety limits on suction force, duration of operation, and overfilling of the wound fluid collection device.

In some embodiments, the wound treatment device chamber can generally have some degree of convexity or concaveness, e.g. or to allow it to be pulled down so as to contact a full thickness wound. Figure 33a illustrates the concave surface of the wound treatment device chamber. The wound treatment device chamber (which is concave with respect to the device when applied) has a wound perimeter area 330, which rests on the perimeter of the wound. . The engineered structure 40 interfaces with the wound surface during use of the device. The engineered structure can directly contact the wound surface. A concave surface of the wound treatment device chamber may be desirable in certain cases, such as deep wounds. In deep wounds, the underside of the device can be pulled into the deep portion of the wound to provide negative pressure wound closure therapy and micromechanical forces across the deep wound surface. As shown in FIG. 33b, the wound treatment device chamber has a concave upper structure 350. As shown in FIG. The concave surface of the upper structure of the device can provide folds that extend deep into the wound to create channels for air and fluid flow.

According to one or more embodiments, a kit for wound treatment comprises a wound treatment device, a formulated therapeutic agent, and/or a wound fluid collection device as described herein is possible. The kit can further include instructions for using one or more of the components for wound treatment.

The function and advantages of these and other embodiments of the materials and methods disclosed herein will be more fully understood from the examples below. The following examples are intended to illustrate the benefits of the disclosed materials and methods and do not exemplify their full scope.

EXAMPLE A pig study was performed. A maximum of 14 partial thickness burns were produced on the dorsum of each pig. Burn wounds were then infected with Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter baumannii, or Candida albicans, followed by 1000×MIC of topical vancomycin, gentamicin, each formulated in 0.625% alginate hydrogel. , minocycline, or topical diflucan at 10xMIC for 7 days individually. A wound care device as described herein was used in conjunction with antibiotic therapy. Sulfadiazine silver cream (Silvaden), blank 0.625% alginate hydrogel and IV antibiotic were used as controls for each topical antibiotic hydrogel. On day 7, immediately after euthanasia, 6 mm wound tissue punch biopsies were collected from each wound and flash frozen for quantitative bacteriological analysis.

According to Figure 34a, results from burns infected with Acinetobacter baumannii showed that topical treatment with 1000xMIC minocycline hydrogel was more effective than IV minocycline and dry controls (p<0.001 and p<0.01, respectively). It was also shown that it can effectively reduce the number of bacteria. According to Figure 34b, in burns infected with Pseudomonas aeruginosa, 1000x MIC gentamicin hydrogel was treated with Silvaden cream (p<0.01), blank hydrogel (p<0.01), dry control (p<0.01), .01), and reduced bacterial counts more effectively than IV minocycline. Figure 34c shows that in S. aureus-infected wounds, 1000x MIC minocycline hydrogel was more effective than Silvaden cream (p<0.01) and IV minocycline (p<0.01) in reducing burn injury. reduced the number of bacteria in the tissue inflicted with According to Figure 34d, in wounds infected with Candida albicans, 10xMIC diflucan hydrogel was more efficient than dry controls (p<0.01) and IV diflucan (p<0.01) in burning wounds. It reduced the number of bacteria in the injured tissue.

Thermal stability data for the 0.625% alginate hydrogel is presented in Figure 35a, which shows the differential scanning calorimetry of the hydrogel sample from room temperature to -45°C at a rate of 0.1°C per minute. (DSC) measurements are illustrated. The freezing point is indicated by the positive heat flow into the hydrogel sample during the cooling cycle starting at -17.38°C.

Cumulative drug release data for 0.625% alginate hydrogel is presented in Figure 35b. 500 microliters of hydrogel sample was placed in a transwell membrane plate with 500 microliters of PBS in the bottom well. At each time point, a 100 microliter aliquot was taken from the bottom well, while 100 microliter of fresh PBS was added at the same time. Aliquots were run on liquid chromatography-mass spectrometry (LCMS) to quantify the concentration of each antibiotic.

Rheological data for the 0.625% alginate hydrogel are presented in Figure 35c. On a stress-controlled rheometer, homogenized hydrogels were analyzed via shear rate sweeps and viscosity was calculated as an indication of injectability. The geometry used was a 1 ^o 40mm Cone-and-Plate with a rough surface at a gap of 400 microns.

Storage modulus and loss modulus data for the 0.625% alginate hydrogel are presented in Figure 35d. The storage modulus is greater than the loss modulus, indicating a gel and not a viscous liquid. Also, the elastic modulus is relatively low, demonstrating that it is a very soft hydrogel. A strain sweep has been used to determine the linear viscoelastic area of the hydrogel and a frequency sweep has been used to determine the linear equilibrium modulus plateau of the hydrogel.

Hypothetical Example The goal of this study was to develop a dressing as described herein to relieve pain and reduce or eradicate infection when compared to standard care dressings in human patients. It will be to determine the efficacy of using the wound care device in conjunction with formulated high dose therapeutic agents.

Preclinical studies in pigs have demonstrated that immediate treatment with the wound care device of the present invention halts wound depth progression and prevents infection.

In this study, large but safe doses (1000 x MIC) of gel-state antibiotics and analgesics provided immediate relief to patients with traumatic extremity wounds and burns (5% to 30% of total body surface area). to be used for treatment. There will be 25 standard treatment (control) devices and 25 wound treatment devices according to one or more of the present embodiments used in this study. The device will be left in place for at least 48 hours and up to 96 hours, at which time it will be removed and the wound will be cultured and debridemented. Antibiotic and analgesic concentrations in gels/fluids in the device, as well as those in serum will be measured every 24 hours.

A quantitative bacterial count (CFU) will demonstrate a significant reduction or eradication of infection associated with the devices and formulations described herein compared to standard therapy. Similarly, pain assessed by tonometry and pain analogue scales will demonstrate a reduction or even elimination of pain compared to standard treatment.

Embodiments of the methods, devices and apparatus discussed herein may be applied to the details of construction and arrangement of components set forth in the foregoing description or illustrated in the accompanying drawings. It should be recognized that there is no limitation. The methods, devices and apparatus are capable of implementation in other embodiments and of being practiced or being carried out in various ways. Examples of specific implementations are provided herein for illustrative purposes only and are not intended to be limiting. In particular, acts, elements and features discussed in connection with any one or more embodiments are not intended to be excluded from a similar role in any other embodiment.

Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Any reference herein to an embodiment or element or act of the systems and methods that are presented in the singular can also encompass embodiments that include a plurality of these elements; Any reference to any embodiment or element or act in the plural can also include embodiments containing only a single element. The use of "including," "comprising," "having," "containing," "involving," and variations thereof herein are hereafter is meant to include the items listed in and equivalents thereof, as well as additional items. References to “or” may be construed as inclusive, and any term described using “or” may be combined with a single, two or more of the terms being described. It is designed to be able to show any of the things, and all things. Any references to front and back, left and right, top and bottom, top and bottom, and vertical and horizontal are intended for convenience of description and are intended for the device and device of the present invention. It is not intended to limit the methods or their components to any one positional or spatial orientation.

Having described above several aspects of at least one embodiment, it is to be appreciated that various alterations, modifications, and improvements will readily occur to those skilled in the art. be. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the scope of the invention. Accordingly, the foregoing description and drawings are merely exemplary.

Claims (22)

A kit for treating wounds, said kit comprising:
comprising a wound treatment device, said wound treatment device comprising:
a chamber including an inner surface and a sealing portion defining an isolated treatment space;
a plurality of embossed structures arranged in a predetermined pattern on the inner surface of the chamber;
at least one tube having a first end connected to the chamber;
including
The structure is configured to directly contact a wound and is configured to create a pathway for distributing negative pressure between the inner surface of the chamber and the wound. cage,
The at least one tube is in fluid communication with the isolated treatment space and is selected from the group of applying a negative pressure to the isolated treatment space and applying a therapeutic agent to the wound. is designed to allow at least one
In addition, the kit
A kit comprising a therapeutic agent comprising an antibiotic formulated with a gel at a concentration of up to or at least about 1000x MIC. 3. The kit of claim 1, wherein said therapeutic agent further comprises an analgesic. 3. The kit of claim 1, wherein the formulation of the therapeutic agent comprises saline. 2. The kit of claim 1, wherein the structures have a height of about 0.2 mm to about 5 mm and are spaced apart from each other by about 0.2 mm to about 10 mm. 2. The kit of Claim 1, wherein the structure extends into the isolated treatment space in a direction generally perpendicular to the inner surface of the chamber. Each embossed structure has cones, pyramids, pentagons, hexagons, hemispheres, domes, rods, elongated ridges with rounded sides, and elongated ridges with square sides. 2. The kit of claim 1, having a shape selected from the group consisting of: 3. The kit of claim 1, wherein said chamber is made from a substantially impermeable material. 3. The kit of claim 1, wherein said chamber is made from a substantially transparent material. 2. The kit of claim 1, wherein the at least one tube is further configured to remove wound fluids from the treatment space. 10. The kit of claim 9, further comprising a wound fluid collection device containing absorbent material fluidly connected to the treatment space via the at least one tube. 11. The kit of Claim 10, wherein the collection device includes at least one of an in-line pump, a check valve, and a safety transducer. 2. The kit of claim 1, further comprising a source of negative pressure in communication with said chamber via said at least one tube. 3. The kit of claim 1, further comprising instructions for use of said device and said therapeutic agent for treating wounds. 3. The kit of claim 1, wherein said gel is a hydrogel. A wound treatment system, said wound treatment system comprising:
comprising a wound treatment device, said wound treatment device comprising:
a chamber including an inner surface and a sealing portion defining an isolated treatment space;
a plurality of embossed structures arranged in a predetermined pattern on the inner surface of the chamber;
at least one tube having a first end connected to the chamber;
including
The structure is configured to directly contact a wound and is configured to create a pathway for distributing negative pressure between the inner surface of the chamber and the wound. cage,
The at least one tube is in fluid communication with the isolated treatment space and is selected from the group of applying a negative pressure to the isolated treatment space and applying a therapeutic agent to the wound. is designed to allow at least one
The wound treatment system also includes:
A wound treatment system comprising a wound fluid collection device containing an absorbent material and connected to said isolated treatment space via said at least one tube. 16. The system of Claim 15, wherein the collection device includes at least one of an in-line pump, a check valve, and a safety transducer. 16. The system of Claim 15, further comprising a source of negative pressure in communication with said chamber via said at least one tube. A method of treating a wound, said method comprising:
applying a wound treatment device to the wound to form an isolated treatment space;
delivering to said isolated treatment space at least one therapeutic agent comprising an antibiotic formulated with a gel at a concentration of up to or at least about 1000×MIC. 19. The method of claim 18, wherein said therapeutic agent further comprises an analgesic. 19. The method of claim 18, further comprising subjecting the wound to negative pressure wound closure therapy via the device. 19. The method of claim 18, further comprising subjecting the wound to debridement. 19. The method of claim 18, wherein said gel is a hydrogel.

Images